Liposomal Bupivacaine in Ambulatory Hand Surgery

Phase 3

Withdrawn

• Conditions: Pain
• Interventions: Drug: Liposomal Bupivicaine

• Registration Number: NCT02933814
• Lead Sponsor: Loma Linda University

Brief Summary

This study is being done to evaluate pain management regimens following ambulatory hand surgery. Improved pain control may be associated with decreased complications, decreased pain scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be two groups. One group will receive liposomal bupivacaine. One group will not. The results will be compared.

Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will participate in this study at LLU.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-14
• Study Start: 2018-02-09
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients 18 years of age and over undergoing ambulatory hand surgery involving soft tissue and subfascial structures, including: CMC arthritis, flexor and extensor tendon injury, symptomatic ganglia, hand and finger fractures

Exclusion Criteria

• Patients who are unable to give informed consent to participate in this study
• Patients with a documented history of hypersensitivity reactions to local anesthetic agents
• Patients with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
• Patients who are currently pregnant
• Patients with impaired hepatic function
• Patients with underlying nerve damage or impairment
• Patients with renal impairment/failure
• Patients whose career/livelihood require a great deal of hand dexterity, in whom a complication could cause a significant impact on life and career (ex: musician, dentist)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Liposomal Bupivicaine	Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.

Primary Outcome Measures

Name	Time	Method
Post-operative Opioid Use	At scheduled intervals up to 168 hours post-operatively	Patients will record their opioid use post-operatively

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States